Trial Outcomes & Findings for Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA (NCT NCT03712345)
NCT ID: NCT03712345
Last Updated: 2022-05-26
Results Overview
Number and percentage of participants who experience at least one treatment-emergent adverse event (TEAE) per treatment group.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Week 24
Results posted on
2022-05-26
Participant Flow
Participant milestones
| Measure |
IFX-1 High Dose
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
IFX-1 Low Dose
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
Placebo
Will receive placebo
Placebo: Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
7
|
|
Overall Study
COMPLETED
|
6
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
IFX-1 High Dose
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
IFX-1 Low Dose
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
Placebo
Will receive placebo
Placebo: Placebo
|
|---|---|---|---|
|
Overall Study
Failure to meet randomization criteria
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA
Baseline characteristics by cohort
| Measure |
IFX-1 Low Dose
n=7 Participants
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
IFX-1 High Dose
n=6 Participants
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
Placebo
n=6 Participants
Will receive placebo
Placebo: Placebo
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.0 years
STANDARD_DEVIATION 15.1 • n=39 Participants
|
54.8 years
STANDARD_DEVIATION 12.0 • n=41 Participants
|
56.5 years
STANDARD_DEVIATION 16.2 • n=35 Participants
|
59.1 years
STANDARD_DEVIATION 14.5 • n=31 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
14 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
AAV disease type
GPA
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
|
AAV disease type
MPA
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Safety Analysis Set
Number and percentage of participants who experience at least one treatment-emergent adverse event (TEAE) per treatment group.
Outcome measures
| Measure |
IFX-1 High Dose
n=6 Participants
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
IFX-1 Low Dose
n=7 Participants
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
Placebo
n=6 Participants
Will receive placebo
Placebo: Placebo
|
|---|---|---|---|
|
Number and Percentage of Participants With at Least One TEAE Per Treatment Group.
|
6 Participants
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set
Efficacy Endpoint based on clinical response evaluated through BVAS. Clinical response is defined as a reduction in BVAS of ≥50% and no worsening in any body system and no administration of rescue medication prior to the response assessment.
Outcome measures
| Measure |
IFX-1 High Dose
n=5 Participants
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
IFX-1 Low Dose
n=7 Participants
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
Placebo
n=6 Participants
Will receive placebo
Placebo: Placebo
|
|---|---|---|---|
|
Percentage of Participants Achieving Clinical Response
|
5 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set
Efficacy Endpoint that evaluates participants with complete remission
Outcome measures
| Measure |
IFX-1 High Dose
n=5 Participants
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
IFX-1 Low Dose
n=7 Participants
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
Placebo
n=6 Participants
Will receive placebo
Placebo: Placebo
|
|---|---|---|---|
|
Percentage of Participants With Clinical Remission (BVAS = 0)
|
3 Participants
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Safety Analysis Set
Assess the pharmacokinetic of the investigational medicinal product.
Outcome measures
| Measure |
IFX-1 High Dose
n=3 Participants
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
IFX-1 Low Dose
n=2 Participants
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
Placebo
n=6 Participants
Will receive placebo
Placebo: Placebo
|
|---|---|---|---|
|
IFX-1 Concentration Pre-dose
|
115598.80 ng/mL
Geometric Coefficient of Variation 82.84
|
7258.96 ng/mL
Geometric Coefficient of Variation 45.57
|
38.09 ng/mL
Geometric Coefficient of Variation 137.68
|
SECONDARY outcome
Timeframe: Weeks 1, 4 and 16Population: Safety Analysis Set
Analyze the IMP plasma concentration using a PK model: IFX 1 concentration at predose (0 hours), after the end of the infusion (+10minutes), and at 2, 6, 24, and 48 hours after the start of the infusion for participants in the PK substudy
Outcome measures
| Measure |
IFX-1 High Dose
n=6 Participants
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
IFX-1 Low Dose
n=7 Participants
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
Placebo
n=6 Participants
Will receive placebo
Placebo: Placebo
|
|---|---|---|---|
|
IFX 1 Concentration at Predose (0 Hours), After the End of the Infusion (+10minutes), and at 2, 6, 24, and 48 Hours After the Start of the Infusion for Participants in the PK Substudy
|
NA ng/mL
Geometric Coefficient of Variation NA
Due to early termination of the study, the PK substudy did not enroll the planned number of 15 participants. Only one of the participants randomized to treatment other than Placebo gave initial consent and did not withdraw consent for the PK substudy at a later timepoint, such that the planned analysis could not be performed but data was only listed.
|
NA ng/mL
Geometric Coefficient of Variation NA
Due to early termination of the study, the PK substudy did not enroll the planned number of 15 participants. Only one of the participants randomized to treatment other than Placebo gave initial consent and did not withdraw consent for the PK substudy at a later timepoint, such that the planned analysis could not be performed but data was only listed.
|
NA ng/mL
Geometric Coefficient of Variation NA
Due to early termination of the study, the PK substudy did not enroll the planned number of 15 participants. Only one of the participants randomized to treatment other than Placebo gave initial consent and did not withdraw consent for the PK substudy at a later timepoint, such that the planned analysis could not be performed but data was only listed.
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set
Pharmacodynamic parameter concentration
Outcome measures
| Measure |
IFX-1 High Dose
n=4 Participants
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
IFX-1 Low Dose
n=3 Participants
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
Placebo
n=6 Participants
Will receive placebo
Placebo: Placebo
|
|---|---|---|---|
|
C5a Plasma Concentration
|
9.4475 ng/mL
Standard Deviation 7.9414
|
37.1361 ng/mL
Standard Deviation 9.7106
|
31.6571 ng/mL
Standard Deviation 6.9818
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set
Pharmacodynamic Parameter of IFX-1 blocking activity 2.5 nM
Outcome measures
| Measure |
IFX-1 High Dose
n=3 Participants
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
IFX-1 Low Dose
n=3 Participants
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
Placebo
Will receive placebo
Placebo: Placebo
|
|---|---|---|---|
|
IFX-1 Blocking Activity 2.5 nM
|
103.873 percentage of IFX-1 blocking activity
Standard Deviation 4.667
|
82.383 percentage of IFX-1 blocking activity
Standard Deviation 21.957
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set
Pharmacodynamic Parameter of IFX-1 blocking activity 10 nM
Outcome measures
| Measure |
IFX-1 High Dose
n=3 Participants
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
IFX-1 Low Dose
n=3 Participants
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
Placebo
Will receive placebo
Placebo: Placebo
|
|---|---|---|---|
|
IFX-1 Blocking Activity 10 nM
|
101.693 percentage of IFX-1 blocking activity
Standard Deviation 0.771
|
60.473 percentage of IFX-1 blocking activity
Standard Deviation 29.531
|
—
|
Adverse Events
IFX-1 High Dose
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
IFX-1 Low Dose
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IFX-1 High Dose
n=6 participants at risk
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
IFX-1 Low Dose
n=7 participants at risk
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
Placebo
n=6 participants at risk
Will receive placebo
Placebo: Placebo
|
|---|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Cardiac disorders
Myocardial infarction
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
General disorders
Asthenia
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Investigations
Troponin increased
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
1/6 • Number of events 2 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
Other adverse events
| Measure |
IFX-1 High Dose
n=6 participants at risk
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
IFX-1 Low Dose
n=7 participants at risk
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
IFX-1: Single IV infusions of IFX-1
|
Placebo
n=6 participants at risk
Will receive placebo
Placebo: Placebo
|
|---|---|---|---|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
33.3%
2/6 • Number of events 2 • 26 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Infections and infestations
Otitis media acute
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 2 • 26 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 2 • 26 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Gastrointestinal disorders
Oral lichen planus
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Investigations
Weight increased
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Investigations
Blood immunoglobulin G
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Investigations
Blood potassium increased
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • Number of events 2 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 2 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 2 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal paraesthesia
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
General disorders
Peripheral swelling
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
General disorders
Adverse drug reaction
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
General disorders
Fatigue
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
16.7%
1/6 • Number of events 2 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
28.6%
2/7 • Number of events 2 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
Ageusia
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Nail bed bleeding
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 2 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • 26 weeks
|
28.6%
2/7 • Number of events 2 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • 26 weeks
|
28.6%
2/7 • Number of events 2 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Eye disorders
Night blindness
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Eye disorders
Scleritis
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Psychiatric disorders
Anhedonia
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • 26 weeks
|
14.3%
1/7 • Number of events 1 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/6 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
16.7%
1/6 • Number of events 2 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal rash
|
16.7%
1/6 • Number of events 1 • 26 weeks
|
0.00%
0/7 • 26 weeks
|
0.00%
0/6 • 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place